Approval · Notice of Compliance 8192 · 2006
FABRAZYME: Notice of Compliance 8192
Issued August 3, 2006
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 8192
- Date
- August 3, 2006
- Company
- Genzyme Canada Inc
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Expanded indication - long-term enzyme replacement therapy in patients with a confirmed diagnosis of fabry disease
- Therapeutic class
- Enzyme replacement therapy
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FABRAZYME | Not yet assigned | — |
Medicinal ingredients
- AGALSIDASE BETA 35 MG per VIAL
- AGALSIDASE BETA 5 MG per VIAL